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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM INC. ANIMAS VIBE OYC

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DEXCOM INC. ANIMAS VIBE OYC Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to animas. If the device is returned, an evaluation shall be completed and a supplemental report will be filed. No conclusions can be made at this time.
 
Event Description
On (b)(6) 2016, the reporter contacted animas alleging a cgm (dex 076) issue. It was alleged that the sensor wire broke off in the patient's abdomen. The patient was able to remove the segment of wire. There was no indication that the product caused or contributed to blood glucose excursion or infections. This complaint is being reported because the sensor broke off.
 
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Brand NameANIMAS VIBE
Type of DeviceOYC
Manufacturer (Section D)
DEXCOM INC.
6340 sequence dr
san diego CA 92121 4356
Manufacturer (Section G)
DEXCOM INC.
6340 sequence dr
san diego CA 92121 4356
Manufacturer Contact
6340 sequence dr
san diego, CA 92121-4356
MDR Report Key6026854
MDR Text Key57576562
Report Number2531779-2016-28414
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 09/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number1-MCBC-3760
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received09/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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